Efficacy and Safety of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms

Intracranial Aneurysm Clinical Trial

Official title:

Efficacy and Safety of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms: A Prospective, Multi-center, Randomized, Open, Positive-controlled, Non-inferiority Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04799964
• Other study ID #: ZHTQ2020001
• Status: Recruiting
• Phase: N/A
• Start date: August 12, 2021
• Est. completion date: December 2023

Study information

• Verified date: September 2023
• Source: Zhuhai Tonbridge Medical Tech. Co., Ltd.
• Contact: Danqing Shen
• Phone: 15858207851
• Email: dq.shen[@]ton-bridge.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of the Flow Diverter (Tonbridge) for endovascular treatment of intracranial aneurysms.

Description:

This is a prospective, multi-center, randomized, open, positive-controlled, non-inferiority trial. This clinical trial is conducted at more than 5 centers in China. Eligible patients are randomized into experimental group using Flow Diverter (Tonbridge) or control group using Tubridge (MicroPort) in a 1:1 ratio. The primary objective of this study is to verify the complete occlusion rate of aneurysms at 12 months of Flow Diverter (Tonbridge) is non-inferior to Tubridge, for treatment of intracranial aneurysms, and evaluate the effectiveness and safety of the Flow Diverter (Tonbridge).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 187
• Est. completion date: December 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18 to 80 years, any gender;

• Unruptured intracranial aneurysms locate in the internal carotid artery (ICA) or vertebral artery (VA) with a neck = 4 mm and a maximal diameter = 10 mm, which diagnosed by DSA;

• The target aneurysm with a parent vessel diameter of 2.0-6.5 mm;

• Subject or guardian is able to understand the purpose of study, shows sufficient compliance with the study protocol and provides a signed informed consent form.

Exclusion Criteria:

• Diagnosed as multiple aneurysms which cannot be covered by a single stent or with cerebrovascular malformations;

• Subarachnoid hemorrhage of the target aneurysm within 30 days pre-procedure;

• Modified Rankin Scale (mRS) score > 2 in pre-procedure;

• Platelet (PLT) < 60×10^9/L or known platelet dysfunction or International Normalized Ratio (INR) > 1.5;

• Heart, lung, liver and renal failure or other severe diseases (such as brain tumor, systemic infection, disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe psychosis);

• The lesion which is not appropriate for flow diverter delivery and deployment judged by investigators (severe stenosis of parent artery, severe tortuosity of parent artery, stent failing to reach the lesion, etc.);

• Major surgery within 30 days before enrollment, or intending to receive surgery within 180 days after enrollment;

• Allergic history of anesthetics and contrast agents, or contraindication for dual antiplatelet or/and anticoagulant therapy;

• Allergic History of metals such as nickel-titanium alloy;

• Life expectancy < 12 months;

• Pregnant or breastfeeding women;

• Subject has participated in other drug or medical device clinical trials within 1 month before signing informed consent;

• Other conditions judged by the investigators as unsuitable for enrollment.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• Flow Diverter (Tonbridge)
The device is a self-expanding vascular stent system, which consists of a stent and a delivery system. The stent is made of platinum core nickel-titanium alloy material. The delivery system is composed of a delivery guide wire and an introducer sheath. The stent and the delivery guide wire are pre-installed in the introducer sheath.
• Tubridge (MicroPort)
Tubridge consists of a stent system and a microcatheter system. The stent system consists of a stent and a conveyor, the stent is self-expanding as well.

Locations

Country	Name	City	State
China	Hunan Provincial People's Hospital	Changsha	Hunan
China	Nanfang Hospital Southern Medical University	Guangzhou	Guangdong
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Hospital	Hangzhou	Zhejiang
China	The First Affiliated Hospital of USTC	Hefei	Anhui
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Nanyang Central Hospital	Nanyang	Henan
China	Changhai Hospital of Shanghai	Shanghai
China	Huashan Hospital Fudan University	Shanghai
China	Yichang Central People's Hospital	Yichang	Hubei
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Zhuhai Tonbridge Medical Tech. Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete occlusion rate of aneurysms at 12 months	Complete occlusion is defined as no contrast agent in the aneurysm (Raymond-Roy class I) which is diagnosed by cerebrovascular DSA at 12 months post-procedure.	360±45 days post-procedure
Secondary	Immediate procedural success rate	Intraoperative cerebrovascular DSA is performed to determine whether the investigational device positions exactly and covers the aneurysm neck effectively.	intra-procedure
Secondary	Complete occlusion rate of aneurysms at 6 months	Complete occlusion is defined as no contrast agent in the aneurysm (Raymond-Roy class I) which is diagnosed by MRA/CTA at 6 months post-procedure.	180±30 days post-procedure
Secondary	Subtotal occlusion rate	Subtotal occlusion is defined as contrast agents in the aneurysm sac less than 10% which is diagnosed by DSA at 12 months post-procedure.	360±45 days post-procedure
Secondary	Incidence of technical complications	Technical complications include but not limited to: stent incomplete opening, stent migration, stent herniation into the aneurysm sac, in-stent thrombosis, operation injury, etc.	intra-procedure
Secondary	Incidence of stroke	Stroke includes hemorrhagic stroke and symptomatic ischemic stroke.	within 360±45 days
Secondary	Incidence of parent artery stenosis ( > 50%) in target area at 360 days and incidence of parent artery occlusion in target area at 360 days	Parent artery stenosis in target area is defined as stenosis degree > 50%. Using postoperative cerebrovascular DSA at 360 days is performed to determine.	360±45 days post-procedure
Secondary	Incidence of adverse events and incidence of serious adverse events	"Incidence of adverse events" is the proportion of subjects with adverse events using the investigational device or the comparator; "Incidence of serious adverse events" is the proportion of subjects with serious adverse events using the investigational device or the comparator.	within 360±45 days
Secondary	Mortality rate	Deaths due to any cause are calculated.	within 360±45 days
Secondary	Operation satisfaction rate	The 5-point Likert scale is used to evaluate the operation satisfaction from three aspects: push performance, retracting performance and release performance. "Operation satisfaction rate" is defined as the proportion of investigational devices or comparators with Likert score = 12 points.	intra-procedure
Secondary	Incidence of device deficiency	Device deficiency is the unreasonable risk that may endanger human health and life safety in the normal use of medical devices during clinical trials, such as labeling errors, quality problems, malfunctions, etc.	within 360±45 days